Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The incidence of bone fractures later in life is higher amongst women who have previously suffered from anorexia (eating disorder). The purpose of this trial is to investigate whether treatment with vitamin D, in either a standard or a high dose, can improve bone health in female patients with anorexia. The study will provide information on vitamin D metabolism in anorexia and on what doses are to be recommended in that disease.

Who can participate?
Female patients with anorexia and female blood donors, who are over 18 years, can participate in this study.

What does the study involve?
The study is a randomized, double-blind prospective , two center trial . The study will compare daily vitamin D3 supplementation with either a standard dose (400 IUs (n =  50 ) or a higher dose with a target S-25 (OH) vitamin D concentration 75-125 nmol/L (n=50). The patients (100) are followed for two years with bloodsamples , anthropometric measurements and DEXA. As comparison a group of female blood donors (100) are used.

What are the possible benefits and risks of participating?
Possible benefits: an increased understanding of bone disease in anorexia and of suitable doses of vitamin D in anorexia.
Possible risks: a small risk of side effects from vitamin D and calcium exists (constipation, nausea, abdominal pain, diarrhea and an even smaller risk of kidney stones).

Where is the study run from?
The study is run from Kalmar and Linköping, Sweden.

When is the study starting and how long is it expected to run for?
The study started in February 2013 and is expected to continue until February 2016.

Who is funding the study?
The study is funded by FORSS: Medical Council of Southeast Sweden.

Who is the main contact?
Dr Pär Wanby

Trial website

Contact information



Primary contact

Dr Pär Wanby


Contact details

Sec of EWndocrinology
Dept of Internal Medicine
County Hospital of Kalmar
SE 392 47 Kalmar
+46 480 448204

Additional identifiers

EudraCT number

2011-005228-17 number

Protocol/serial number


Study information

Scientific title

Does treatment with vitamin D lower the incidence of osteoporosis in female patients with anorexia?


Study hypothesis

Treatment with high doses of vitamin D lowers the incidence of osteoporosis in patients with anorexia nervosa.

Ethics approval

Dnr 2012/145-31 (EPN Linköping, Sweden 2012-05-23)

Study design

Randomised controlled study.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.


1. Anorexia nervosa (weight fobia, BMI < 17.5, lack of menstration for 3 consecutive months).
2. Osteoporosis


100 female patients with anorexia nervosa are randomised to two groups. Bone markers and bone density are followed throughout the study.
1. 1 tablet of: Calcium carbonate 500 mg + Colecalciferol 400 IE p os daily
2. 1 tablet of: Calcium carbonate 500 mg + Colecalciferol 400 IE p os daily + Colecalciferol (oil drops 80 IE/drop) p os.daily. The initial dose of the vitamin D oil drops is 1600 IE. This dose is adjusted from the patients plasma concentration of vitamin D (goal: 90 - 125 nmol/L). The total dose of vitamin D is not to exceed 4000 IE/day.

Each patient is on either of these two treatments for two years and is also monitored for this period of time.
Control group: blood donors

Intervention type



Not Specified

Drug names

Primary outcome measure

Bone density: C-teleopeptide of collagen type I (s-CTX) and osteocalcin
25-OH vitamin D3 is measured at baseline, 1, 2, 3, 6, 12, 18 and 24 months. A dual energy X-ray absorptiometry (DXA) is performed at baseline, after 12 and 24 months. Pituitary hormones and after 24 months. Bone markers (C-teleopeptide of collagen type I, osteocaline) are measured at baseline and at 6, 12, 18 and 24 months.

Secondary outcome measures

Omega-3 fatty acids, insulin resistance and pituitary hormones. Glucose and insulin are measured at baseline and 18 months.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. 100 female (age above 18 years) patients that fullfill the criteria of anorexia nervosa, are willing to participate in the study and do not fullfill the exclusion criteria.
2. 100 female blood doners with an age above 18, and willing to participate in the study.

Participant type


Age group




Target number of participants

100 patients with anorexia + 100 controll subjects (blood doners).

Participant exclusion criteria

1. Treatment with litium, bisfosfonates, antiepileptics or cortison
2. Allergy towards any substance that are part of the vitamin D or calcium medication of the study or allergy towards soja, peanats
3. Hyperkalcemia, a history of kidney stones or a vitamin D plasma concentration (25-OH-D3 ) >90 nmol/L or an estimated GFR < 40 ml/min
4. Pregnancy

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Sec of EWndocrinology
SE 392 47 Kalmar

Sponsor information


Kalmar County Hospital (Sweden)

Sponsor details

c/o Pär Wanby
Section of Endocrinology
Dept of Internal Medicine
SE 391 85
+46 (0) 48 044 8204

Sponsor type

Hospital/treatment centre



Funder type

Research council

Funder name

FORSS: Medical Research Council of Southeast Sweden (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/02/2017: The overall trial end date has been updated from 01/02/2016 to 31/12/2017